This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.
Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening but no more than 12 years post injury.
Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.
had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 6 months prior to screening. Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.
Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.
Single group
EG110A
DrugParticipants treated with EG110A
Incidence of treatment-emergent adverse events (TEAEs)
Any participant who has a reported treatment-emergent adverse events (TEAEs)
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline
Changes in urodynamic variables will be assessed at Weeks 12 and 52.
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline
7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization.
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Cyllene Therapeutics
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
